Y-Stent with Tracheal Posts with 1mm Wall Thickness

GUDID 00815347020082

E. Benson Hood Laboratories Y-Stent

HOOD, E BENSON LABORATORIES INC

Tracheostomy tube, non-reinforced, non-customized, single-use
Primary Device ID00815347020082
NIH Device Record Key89ccdb12-ed01-44f3-ba82-b4fb180dedbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameY-Stent with Tracheal Posts with 1mm Wall Thickness
Version Model NumberYS1-1512-S
Company DUNS076603380
Company NameHOOD, E BENSON LABORATORIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815347020082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWAProsthesis, Tracheal, Preformed/Molded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00815347020082]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-29
Device Publish Date2023-11-21

On-Brand Devices [Y-Stent with Tracheal Posts with 1mm Wall Thickness]

00815347024035E. Benson Hood Laboratories Y-Stent
00815347024028E. Benson Hood Laboratories Y-Stent
00815347020099E. Benson Hood Laboratories Y-Stent
00815347020082E. Benson Hood Laboratories Y-Stent

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